510(k) K111912 ยท IZL System, X-Ray, Mobile
MOBILETT MIRA
| Applicant | Siemens Medical Solutions USA, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Sep 19, 2011 |
| Received | Jul 5, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111912
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 14, 2023 | Siemens Medical Solutions USA, Inc Mobilett Mira wireless (VA20) mobile x-ray system(s) Open, Classified |
IZL | None listed |
| Aug 5, 2013 | Siemens Medical Solutions USA, Inc Mobiletta Mira
Mobile X-ray System Terminated |
IZL | None listed |
| Dec 6, 2012 | Siemens Medical Solutions USA, Inc Siemens Mobilette Mira, intended use as Mobile x-ray system. Terminated |
IZL | None listed |
| Sep 11, 2012 | Siemens Medical Solutions USA, Inc Siemens Mobilett Mira mobile x-ray system
Product Usage:
Mobile x-ray system Terminated |
IZL | None listed |
| Sep 6, 2012 | Siemens Medical Solutions USA, Inc Siemens Mobilett Mira.
Mobile X-Ray System. Terminated |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.